不适合移植的大 B 细胞淋巴瘤二线使用 axicabtagene ciloleucel：ALYCANTE 最终分析
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CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
舒格利单抗单药治疗复发/难治性结外自然杀伤/T 细胞淋巴瘤患者（GEMSTONE-201）：一项单臂、多中心、II 期研究结果
英文原题：Sugemalimab Monotherapy for Patients With Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (GEMSTONE-201): Results From a Single-Arm, Multicenter, Phase II Study.
查看英文原题
Sugemalimab Monotherapy for Patients With Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (GEMSTONE-201): Results From a Single-Arm, Multicenter, Phase II Study.
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研究概要
舒格利单抗在 R/R ENKTL 中显示出强效且持久的抗肿瘤活性。治疗耐受性良好，安全性特征与该类药物预期一致。
研究思路结论见上方概要
目的
复发/难治性结外自然杀伤/T细胞淋巴瘤（R/R ENKTL）是一种罕见且侵袭性强的非霍奇金淋巴瘤，治疗选择有限。这项II期研究评估了sugemalimab（一种抗PD-L1单克隆抗体）在R/R ENKTL中的疗效和安全性。
方法
符合条件的患者接受sugemalimab 1,200 mg静脉注射，每3周一次，最长24个月或直至疾病进展、死亡或退出研究。主要终点是由独立放射学审查委员会评估的客观缓解率（ORR）。关键次要终点包括由研究者评估的ORR、完全缓解率、缓解持续时间和安全性。
结果
截至数据截止日期（2022年2月23日），共入组80例患者，中位随访时间为18.7个月。基线时，54例（67.5%）为IV期疾病，39例（48.8%）既往接受过≥2线全身治疗。独立放射学审查委员会评估的ORR为44.9%（95% CI，33.6至56.6）；28例（35.9%）患者达到完全缓解，7例（9.0%）达到部分缓解，12个月缓解持续率为82.5%（95% CI，62.0至92.6）。研究者评估的ORR为45.6%（95% CI，34.3至57.2），24例（30.4%）患者达到完全缓解。大多数治疗中出现的不良事件严重程度为1-2级，32例（40.0%）患者报告了≥3级事件。
展开英文摘要原文
PURPOSE
Relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) is a rare and aggressive type of non-Hodgkin lymphoma with limited treatment options. This phase II study evaluated the efficacy and safety of sugemalimab, an anti-PD-L1 monoclonal antibody, in R/R ENKTL.
METHODS
Eligible patients received sugemalimab 1,200 mg intravenously once every 3 weeks for up to 24 months or until progression, death, or study withdrawal. The primary end point was objective response rate (ORR) assessed by an independent radiologic review committee. Key secondary end points included ORR assessed by the investigators, complete response rate, duration of response, and safety.
RESULTS
At the data cutoff (February 23, 2022), 80 patients were enrolled and followed for a median of 18.7 months. At baseline, 54 (67.5%) had stage IV disease and 39 (48.8%) had received ≥2 lines of prior systemic therapy. Independent radiologic review committee-assessed ORR was 44.9% (95% CI, 33.6 to 56.6); 28 (35.9%) patients achieved a complete response and seven (9.0%) achieved a partial response, with a 12-month duration of response rate of 82.5% (95% CI, 62.0 to 92.6). Investigator-assessed ORR was 45.6% (95% CI, 34.3 to 57.2), and 24 (30.4%) patients achieved a complete response. Most treatment-emergent adverse events were grade 1-2 in severity, and grade ≥ 3 events were reported in 32 (40.0%) patients.
CONCLUSION
Sugemalimab showed robust and durable antitumor activity in R/R ENKTL. Treatment was well tolerated with expected safety profile for this drug class.
论文信息
- 作者
- Huang H、Tao R、Hao S、Yang Y、Cen H、Zhou H、Guo Y、Zou L
- 第一作者单位
- Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.China
- 通讯作者单位
- Clinical Department, CStone Pharmaceuticals (Suzhou) Co Ltd, Suzhou, China.China
- 文献类型
- II 期临床试验 · 多中心研究 · 非美国政府资助研究
- 期刊
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology2023 Jun 1
- 原文标识
- PubMed 36996373 · DOI 10.1200/JCO.22.02367
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